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A Study of E6011 in Participants With Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
E6011
Placebo
Sponsored by
EA Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, E6011, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal tract

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent.
  2. With a baseline (at week 0 before the start of investigational medicinal product [IMP] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34.
  3. With a SES-CD >=7 (or for participants with isolated ileal disease, >=4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >=1 in any segment) assessed by colonoscopy and confirmed by a centralised review.
  4. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering biologic(s) (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance).
  5. If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
  6. If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
  7. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.

Exclusion Criteria:

  1. Diagnosed with ulcerative colitis or indeterminate colitis.
  2. Diagnosed with gastrointestinal epithelial dysplasia.
  3. Who have an abscess or are suspected to have one.
  4. With an artificial anus, ileo-anal pouch or fistula.
  5. With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.).
  6. Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.

Sites / Locations

  • 49, CCR Ostrava, s.r.o
  • 15, University of Debrecen Clinical Centre
  • 19, Semmelweis university
  • 4
  • 17
  • 10
  • 31
  • 27
  • 39
  • 29
  • 41
  • 38
  • 26
  • 37
  • 7
  • 32
  • 8
  • 52
  • 30
  • 28
  • 42
  • 51
  • 50
  • 2
  • 33
  • 34
  • 3
  • 6
  • 43
  • 1
  • 36
  • 25
  • 35
  • 11
  • 5
  • 40
  • 24
  • 21, Vitamed Galaj i Cichomski sp.j.
  • 22, Vita Longa
  • 20, Clinical Research Center sp. z o.o., Medic-R Sp. k.
  • 23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy
  • 45, Federal Siberian Research and Clinical Center
  • 44, LLC, Novosibirskiy Gastrocenter
  • 46, Pyatigorsk City Clinical Hospital
  • 48, LLC Clinic, UZI 4D
  • 47, City Hospital of Saint Martyr Elizaveth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E6011

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Response (CR) 100 (CR100)
CR100 is defined as clinical response with a decrease of greater than or equal to (>=) 100 points in CDAI score from Baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

Secondary Outcome Measures

Percentage of Participants with CR70 and CR100
CR70 is defined as CR with a decrease of >=70 points in CDAI score from baseline. CR100 is defined as clinical response with a decrease of >=100 points in CDAI score from baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Percentage of Participants With Below 150 Points (CDAI Remission Rate)
CDAI remission is defined as CDAI score below 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)
Patient reported outcome 2-clinical response 5 (PRO2-CR5) is defined as CR with a decrease of 5 or more points in PRO2 score from baseline. Patient reported outcome 2-clinical response 8 (PRO2-CR8) is defined as CR with a decrease of 8 or more points in PRO2 score from baseline. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Percentage of Participants With Below 8 Points (PRO2-remission Rate)
PRO2-remission is defined as PRO2 below 8 points. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score
Endoscopic response is defined as a decrease in SES-CD of at least 50 percent (%) from baseline. SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Percentage of Participants With Endoscopic Remission Based on SES-CD Score
Endoscopic remission is defined as 2 or less points on SES-CD. SES-CD scores are calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: Rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Change From Baseline in CDAI Score
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Percent Change From Baseline in CDAI score
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Change From Baseline in PRO2
PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Percent Change From Baseline in PRO2
PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Change From Baseline in SES-CD Score
SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Percent Change From Baseline in SES-CD Score
SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Percentage of Participants who Achieved Steroid-free Remission
Steroid-free remission will be achieved through steroid dose reduction and clinical remission (CDAI remission or PRO2-remission). CDAI remission is defined as CDAI score below 150 points. PRO2-remission is defined as PRO2- score less than 8-points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Percentage of Participants who Achieved Steroid-Free Improvement
Steroid-free improvement will be achieved by steroid dose reduction and CR of CR70, CR100, PRO2-CR5 or PRO2-CR8. CR70 is CR with decrease of >=70 points and CR100 is CR with decrease >=100 points in CDAI from Baseline. PRO2-CR5 is CR with decrease of >=5 points and PRO2-CR8 is CR with decrease of >=8 points from baseline. CDAI consisting of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids

Full Information

First Posted
November 5, 2018
Last Updated
September 5, 2023
Sponsor
EA Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03733314
Brief Title
A Study of E6011 in Participants With Active Crohn's Disease
Official Title
Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EA Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.
Detailed Description
Participants with moderate to severe Crohn's disease will be enrolled in this study. The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period. At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued. The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, E6011, Inflammatory Bowel Diseases, Gastroenteritis, Gastrointestinal tract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E6011
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E6011
Intervention Description
E6011, infusion, intravenously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, infusion, intravenously.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response (CR) 100 (CR100)
Description
CR100 is defined as clinical response with a decrease of greater than or equal to (>=) 100 points in CDAI score from Baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants with CR70 and CR100
Description
CR70 is defined as CR with a decrease of >=70 points in CDAI score from baseline. CR100 is defined as clinical response with a decrease of >=100 points in CDAI score from baseline. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percentage of Participants With Below 150 Points (CDAI Remission Rate)
Description
CDAI remission is defined as CDAI score below 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)
Description
Patient reported outcome 2-clinical response 5 (PRO2-CR5) is defined as CR with a decrease of 5 or more points in PRO2 score from baseline. Patient reported outcome 2-clinical response 8 (PRO2-CR8) is defined as CR with a decrease of 8 or more points in PRO2 score from baseline. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percentage of Participants With Below 8 Points (PRO2-remission Rate)
Description
PRO2-remission is defined as PRO2 below 8 points. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) Score
Description
Endoscopic response is defined as a decrease in SES-CD of at least 50 percent (%) from baseline. SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Time Frame
Week 12
Title
Percentage of Participants With Endoscopic Remission Based on SES-CD Score
Description
Endoscopic remission is defined as 2 or less points on SES-CD. SES-CD scores are calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: Rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Time Frame
Week 12
Title
Change From Baseline in CDAI Score
Description
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percent Change From Baseline in CDAI score
Description
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Change From Baseline in PRO2
Description
PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percent Change From Baseline in PRO2
Description
PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Change From Baseline in SES-CD Score
Description
SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Time Frame
Week 12
Title
Percent Change From Baseline in SES-CD Score
Description
SES-CD scores will be calculated by totaling the points for: size of ulcers, ulcerated surface, affected surface, and presence of stenosis. It will be graded on a 4-point scale (0-3) in each of the five segments: rectum, left colon, transverse colon, right colon, and terminal ileum. Scale goes from 0 to 60 with a higher score indicating greater severity of disease.
Time Frame
Week 12
Title
Percentage of Participants who Achieved Steroid-free Remission
Description
Steroid-free remission will be achieved through steroid dose reduction and clinical remission (CDAI remission or PRO2-remission). CDAI remission is defined as CDAI score below 150 points. PRO2-remission is defined as PRO2- score less than 8-points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percentage of Participants who Achieved Steroid-Free Improvement
Description
Steroid-free improvement will be achieved by steroid dose reduction and CR of CR70, CR100, PRO2-CR5 or PRO2-CR8. CR70 is CR with decrease of >=70 points and CR100 is CR with decrease >=100 points in CDAI from Baseline. PRO2-CR5 is CR with decrease of >=5 points and PRO2-CR8 is CR with decrease of >=8 points from baseline. CDAI consisting of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, haematocrit, and body weight. CDAI scores range from 0 to 600, higher score indicates higher disease activity. PRO2 is a composite index consisting of weighted scoring of 2 disease variables: number of liquid stools, extent of abdominal pain. PRO2 scores range from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame
Up to Week 64
Title
Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids
Time Frame
Up to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent. With a baseline (at week 0 before the start of investigational medicinal product [IMP] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34. With a SES-CD >=7 (or for participants with isolated ileal disease, >=4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore >=1 in any segment) assessed by colonoscopy and confirmed by a centralised review. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering biologic(s) (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance). If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration. Exclusion Criteria: Diagnosed with ulcerative colitis or indeterminate colitis. Diagnosed with gastrointestinal epithelial dysplasia. Who have an abscess or are suspected to have one. With an artificial anus, ileo-anal pouch or fistula. With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.). Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.
Facility Information:
Facility Name
49, CCR Ostrava, s.r.o
City
Ostrava
Country
Czechia
Facility Name
15, University of Debrecen Clinical Centre
City
Debrecen
Country
Hungary
Facility Name
19, Semmelweis university
City
Győr
Country
Hungary
Facility Name
4
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
17
City
Toyota
State/Province
Aichi
Country
Japan
Facility Name
10
City
Abiko
State/Province
Chiba
Country
Japan
Facility Name
31
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
27
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
39
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
29
City
Kasamatsu
State/Province
Gifu
Country
Japan
Facility Name
41
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
38
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
26
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
37
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
7
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
32
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
8
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
52
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
30
City
Ōiso
State/Province
Kanagawa
Country
Japan
Facility Name
28
City
Urasoe
State/Province
Okinawa
Country
Japan
Facility Name
42
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
51
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
50
City
Shuntougun
State/Province
Shizuoka
Country
Japan
Facility Name
2
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
33
City
Hachiōji
State/Province
Tokyo
Country
Japan
Facility Name
34
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
3
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
6
City
Mitaka
State/Province
Tokyo
Country
Japan
Facility Name
43
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
1
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
36
City
Akita
Country
Japan
Facility Name
25
City
Fukuoka
Country
Japan
Facility Name
35
City
Fukuoka
Country
Japan
Facility Name
11
City
Gifu
Country
Japan
Facility Name
5
City
Kagoshima
Country
Japan
Facility Name
40
City
Kanazawa
Country
Japan
Facility Name
24
City
Osaka
Country
Japan
Facility Name
21, Vitamed Galaj i Cichomski sp.j.
City
Bydgoszcz
Country
Poland
Facility Name
22, Vita Longa
City
Katowice
Country
Poland
Facility Name
20, Clinical Research Center sp. z o.o., Medic-R Sp. k.
City
Poznań
Country
Poland
Facility Name
23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy
City
Wrocław
Country
Poland
Facility Name
45, Federal Siberian Research and Clinical Center
City
Krasnoyarsk
Country
Russian Federation
Facility Name
44, LLC, Novosibirskiy Gastrocenter
City
Novosibirsk
Country
Russian Federation
Facility Name
46, Pyatigorsk City Clinical Hospital
City
Pyatigorsk
Country
Russian Federation
Facility Name
48, LLC Clinic, UZI 4D
City
Pyatigorsk
Country
Russian Federation
Facility Name
47, City Hospital of Saint Martyr Elizaveth
City
Saint Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Learn more about this trial

A Study of E6011 in Participants With Active Crohn's Disease

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